- Eisai, Inc (Nutley, NJ)
- …make a difference. If this is your profile, we want to hear from you. The Director , Global Regulatory , Growth Markets will be responsible for providing ... management of staff.Determining timelines and budgets for program activities and report accordingly. Lead and participate in global regulatory initiatives and… more
- Insmed Incorporated (NJ)
- …each other, and for the future of science, we're in. Are you?About the Role:The Global Regulatory Lead (GRL) will be responsible for formulating and ... product development and submission activities. The GRL will serve as the global regulatory lead for documentation review prepared by other technical… more
- Bayer (Whippany, NJ)
- …brilliant and diverse minds to make a real difference, there’s only one choice. Sr Director , Global Clinical Lead , Diagnostic Molecular Imaging The Senior ... Director , Global Clinical Lead Diagnostic Molecular Imaging is...internal Radiology capabilities, partners, thought- leader communities, vendors, regulatory authorities, and other external partners; Lead or… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …other research areas centered around rare diseases and immune disorders. Job Summary Director , Global Oncology Forecasting will be responsible for leading and ... oncology assets and will be reporting to the Senior Director , Global Business Strategy and Analytics. ... forecasts, ensuring compliance with internal policies and external regulatory requirements. Lead audit readiness and respond to… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …deemed necessary. Ensure inspection readiness are adequately performed and may support and/or lead regulatory inspection activities at DS facilities and / or ... diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi...collaboration with other QA functions and/or applicable stakeholders. Support/ lead and or co lead due- diligence… more
- Eisai, Inc (Philadelphia, PA)
- …is responsible for the leadership and oversight of the Labeling function within Global Regulatory Services and Operations (GRSO). This position will manage ... regulations governing labeling of pharmaceutical products globally, and serves as the global regulatory labeling representative on relevant project teams to… more
- Formation Bio (New York, NY)
- …and marketing Formation Bio's assets. This role includes the lead regulatory responsibility for support of global registration and life cycle support ... treatments to patients faster and more efficiently.About the PositionThe Senior Director , Regulatory Affairs lead is responsible for developing and directing… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. Summary The Associate Director , Global Oncology Medical Affairs, Medical Analytics will be responsible ... for cardiovascular diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily… more
- Genmab (NJ)
- …and serious diseases. We strive to create, champion and maintain a global workplace where individuals' unique contributions are valued and drive innovative solutions ... Then we would love to have you join us!The Role The Associate Director , External Data Quality Management, is a strategic leadership role supporting high-quality… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Expert Panels for select clinical trials, in collaboration with Clinical Director and Clinical Operations lead Support investigator meetings Serve ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...Core Medical Team, at the discretion of the Executive Director Represent NNI Medical Affairs on Global … more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …areas, supporting both clinical and commercial sites. This individual will be a key leader in the Global Quality organization and a champion for quality ... Legend Biotech is a global biotechnology company dedicated to treating, and one...such as inspection readiness, metrics implementation and review, overall regulatory compliance and implementation programs, and others as required.… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionSr. Principal Scientist - Device Technical and Engineering Lead (Sr. Director Equivalent)Our company's Device Product & Process Development (DPPD) ... regulatory , quality, company, and customer requirements.-This position will lead cross-functional development teams within and external to Device Development &… more
- Genmab (NJ)
- …like a fit? Then we would love to have you join us!Overview:The Director , Feasibility Lead , will drive the implementation of strategic, data-driven feasibility ... internal processes, mentoring team members, and contributing to cross-functional strategies.The Director will lead complex feasibility initiatives and serve as… more
- Genmab (NJ)
- …is currently seeking a Director , HEOL (Health Evidence and Outcomes Liaison) Team Lead to be a part of an exciting, passionate, high profile, high impact Medical ... diseases. We strive to create, champion and maintain a global workplace where individuals' unique contributions are valued and...and work in a highly dynamic and collaborative setting.The Director , HEOL Team Lead is part of… more
- Insmed Incorporated (NJ)
- …company and regulatory policies and procedures. In addition, the Senior Director will be responsible, globally, for implementing the safety and risk management ... from regulatory authorities on safety issues for assigned products and lead the integrated safety input into all regulatory documents where required.Maintain… more
- Merck & Co. (Rahway, NJ)
- …and ability to successfully partner cross functionally with all business units, regulatory , legal, and with Global Marketing colleagues Demonstration of computer ... Job DescriptionWe're seeking a Growth- and Improvement-minded leader to build a purpose-built, customer experience-driven omnichannel...engine across our US Animal Health portfolio. You will lead a team that owns digital demand creation and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Operations as part of the Quality team based in Raritan, NJ.Role OverviewThe Sr. Director of Quality will lead Legend CAR-T manufacturing facilities within the ... in full compliance with established cGMP requirements. This individual will be a key leader in the Global Cell Therapy Quality organization and a champion for… more
- Eisai, Inc (Nutley, NJ)
- …along with a proven track record in inspection-facing roles and global regulatory compliance.Essential Functions Clinical Outsourcing Designs and executes ... Director of Clinical Outsourcing provides strategic leadership for global outsourcing and vendor management activities within clinical development. This role… more
- Insmed Incorporated (NJ)
- …(MRC) Operations is responsible for managing the operational execution of the company's Global We're looking for an Associate Director , Medical Review Committee ... so does every person who joins in. As a global biopharmaceutical company dedicated to transforming the lives of...for patients with serious diseases. Reporting to the Senior Director , Medical Review Committee (MRC), you'll be responsible for… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders. Summary: The Senior Director , Clinical Safety, will lead the development and implementation of ... Global Product Team in collaboration with Clinical Development, Regulatory , Project Management, Biostatistics, Pharmacology, and other departments to… more
